Regulatory Specialist
Genalyte
ABOUT GENALYTE
At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.
POSITION SUMMARY
Genalyte, Inc. is seeking a highly skilled and motivated Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate regulatory landscapes, ensuring our groundbreaking products meet all regulatory requirements and reach the market efficiently. If you are passionate about advancing healthcare through cutting-edge technology and thrive in a collaborative environment, we invite you to be a part of our mission to transform diagnostic testing and improve patient outcomes.
The Regulatory Affairs Specialist will assist in defining and executing regulatory strategies, preparing regulatory submissions, interpreting regulations, performing regulatory research, and providing regulatory guidance throughout the product lifecycle. This role will be responsible for preparing submission documents and work cross functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. Supports interactions with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVD/IVDD, CFR and other regulatory requirements.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to:
- Develop and implement regulatory strategies for new IVD products, significant design changes, and sustaining projects to achieve timely market access in target regions
- Collaborate with Quality, Clinical, R&D, Manufacturing, and Commercial teams to align on regulatory objectives, communicate regulatory requirements, and track submission deliverables according to project timelines
- Draft, review, and refine technical documents for regulatory submissions, ensuring alignment with applicable guidance
- Coordinate and manage pre-submissions for prompt FDA responses and feedback
- Support the preparation and submission process for 510(k), PMA, and CE applications
- Oversee the e-STAR regulatory documentation requirements to meet FDA submission standards
- Monitor evolving global IVD regulations (FDA guidances, IVDR updates, harmonization efforts) and assess impact on products/portfolio; develop and implement compliance plans
- Support post-market activities, including vigilance reporting, corrections and removals, field safety corrective actions (FSCA/FSC), periodic safety update reports, and post-market surveillance/performance follow-up
- Support the development, review, and approval of labeling, promotional materials, and marketing claims for regulatory compliance
- Monitor, maintain, and ensure the accuracy of regulatory registrations, certifications, and licenses
- Support external regulatory agency audits, offering regulatory insights to prevent non-compliance issues
- Organize and maintain all regulatory-related documentation meticulously
- Support maintenance and improvement of the company’s Quality Management System (QMS)
- Support the internal audit program as requested
- Perform additional duties as assigned, contributing to the team's success
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- A minimum of a Bachelor’s degree in Science or related discipline of 3 years experience in IVD regulatory affairs or equivalent
- Experience working in a FDA QMSR and ISO 13485 environment
- Certification in regulatory affairs is a bonus
- Excellent understanding of regulations, consensus standards, guidances, and public databases relevant to regulatory research and guidance
- Strong analytical and problem-solving skills
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
- Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
- Must possess a high degree of accuracy and attention to detail
- Ability to communicate effectively with employees across multiple departments
- Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations
- Proficient in Google and Microsoft Office applications - Google Docs, Sheets, Slides; Microsoft Word, Excel, and Powerpoint
- Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines